Manager, Quality Assurance

Manager, Quality Assurance - Home based or Office based - Chennai or Bangalore

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

 

We are looking for an experienced Quality Assurance Manager to join our specialist team, to help support our business areas with corporate systems compliance, complex architecture and interoperability as well as data governance and data integrity.
 

As a Quality Assurance Manager your role will involve:

• Providing cross-functional Quality Assurance expertise, supporting all areas of Data Integrity and Technology Compliance.
• Responsible for the oversight of the Computerized Systems Validation (CSV) review process and qualification deliverables to ensure documentation supports a compliant state.
• Supporting efforts for standardization and advancement of validation / qualification methodologies in support of software, equipment with software and medical devices used in a clinical setting. 
• Responsible for analysing technology related risks and the creation, execution and oversight of Technology Audit schedules (Internal and Vendor).
• Supporting technology focused sponsor audits and inspections.
• Providing guidance to technology and information management groups to ensure the business understands applicability of associated published regulatory guidance or regulations concerning GCP, GLP, GMP, 21CFR Part 11, and Annex 11.
• Supporting training activities focused on advancing Systems Compliance SMEs across Quality and Compliance.
• Developing and fostering positive relationships with business unit customers to ensure a common understanding, approach and appreciation for computerized systems validation (CSV) and technical auditing, with focus on Data Integrity and system integration.
   

As a Quality Assurance Manager you will need:

• Degree level education

• Experience specific to the application or support of software validation and compliance efforts. 
• Experience in QA, with GxP auditing, Data Integrity and CSV
• An understanding of validation and qualification strategies for regulated systems including software and medical devices used in clinical settings
• Demonstrated strength in agile working principles, methodologies, and team structures
• Expert knowledge with audit or inspection management
• Ability to travel as needed to vendor and/or internal sites

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order